Publication Date

January 14, 2022

Press Release

View Press Release

In response to a request for comments from the Food and Drug Administration (FDA) regarding new rules regulating over-the-counter hearing aids, NAAG submitted comments encouraging the FDA to take the below steps to ensure that states maintain a role as regulators in this emerging market:

  1. The FDA should define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.
  2. The FDA should state explicitly the type of state requirements that the final rule would not preempt.
  3. Lastly, the FDA should explicitly state in the final OTC Rule: (a) that the existing processes in place in 21 C.F.R. §808.20 to petition the FDA for a preemption determination will continue to apply, and (b) that the FDA will find against preemption when consistent with the statutory language and “in the public interest.”

**This letter was updated on January 18, 2022, to reflect all attorney general offices that signed the letter.

Lead States

Connecticut, Ohio

Signatory States

AR, AZ, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA, VT, WA, WI, WV